Pharmaceutical compositions of testosterone
a technology of pharmaceutical compositions and testosterone, which is applied in the direction of pharmaceutical delivery mechanisms, medical preparations, endocrine system disorders, etc., can solve the problems of extreme pain and local tissue damage, and achieve the effect of minimizing and/or preventing crystal formation
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example 1
[0050]
TABLE 3Preparation of Testosterone Cypionate composition, 200 mg / mLIngredientsQty / mL% (w / v)Qty / 30 L batchTestosterone cypionate, USP 200 mg 20.% 6 kgBenzyl benzoate 224 mg22.4% 6.72 kgCotton seed oil542.2 mg54.2%16.27 kgBenzyl alcohol 20 mg 2% 0.6 kgTotal986.2 mg98.6%29.59 kg
[0051]Cotton seed oil and benzyl benzoate were added to the vessel and the mixture was heated to a temperature of about 40° C. to 60° C. Testosterone cypionate was added slowly, in lots, under stirring, for about 90 minutes, maintaining the solution temperature between about 40° C. to 60° C. The mixture was stirred for 60 minutes to ensure complete dissolution of testosterone cypionate. Benzyl alcohol was added slowly to the resultant solution at 40° C.-60° C., and continuously stirred for 30 minutes.
[0052]The above-obtained solution was cooled gradually to 23° C. over 3 hours. It was then filtered through a 0.22-micron PVDF filter into a buffer tank. The final solution was filled into USP Type I cle...
example 2
[0058]
TABLE 7Preparation of Testosterone Cypionate composition with varyingamounts of benzyl alcoholComposition AComposition BComposition CIngredientsQuantity in (mg / mL)Testosterone cypionate200200200Benzyl benzoate224224224Cotton seed oil556542.20535.60Benzyl alcohol9.452025Total989.45986.2984.6
[0059]Manufacturing Procedure[0060]1. The quantify of Benzyl benzoate shown in the above table was added to cotton seed oil in a glass beaker and stirred for 10 minutes while heating at 40° C.-45° C. to form a solution.[0061]2. Testosterone cypionate was added to the above solution and stirred until the solution was clear. To this solution, benzyl alcohol was added, and stirred continuously for 10 minutes.[0062]3. The solution volume was made up to 100 mL with cotton seed oil which was stirred for 60 minutes.[0063]4. The bulk solution was filled into 10 mL tubular glass vials.
example 3
[0064]Samples from Compositions A, B and C were tested under various conditions (e.g., either stored immediately, or aged at a certain temperature prior to storage), and then observed for crystal formation over time. These results are summarized in Tables 8-14 below.
[0065]
TABLE 8Observation for crystals in the composition A, B and C, when samplesstored immediately at 10° C.-15° C.DayComposition AComposition BComposition C0 (Initial)Clear pale-yellowClear pale-yellowClear pale-yellowsolutionsolutionsolution1Clear pale-yellowClear pale-yellowClear pale-yellowsolutionsolutionsolution2Needle likeClear pale-yellowClear pale-yellowcrystals weresolutionsolutionobserved3Vials withdrawnClear pale-yellowClear pale-yellow(Studysolutionsolution50discontinued)Clear pale-yellowClear pale-yellowsolutionsolution120Clear pale-yellowClear pale-yellowsolutionsolution
[0066]Samples from Composition A, B and C were loaded or stored immediately at a temperature range of 10° C.-15° C. after preparation (e....
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